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The Impact of TORasemide oN hemodynAmic and Neurohormonal Stress, and carDiac remOdeling in Heart Failure (TORNADO)

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ClinicalTrials.gov Identifier: NCT01942109
Recruitment Status : Unknown
Verified June 2017 by Marcin Grabowski, Medical University of Warsaw.
Recruitment status was:  Recruiting
First Posted : September 13, 2013
Last Update Posted : June 8, 2017
Sponsor:
Information provided by (Responsible Party):
Marcin Grabowski, Medical University of Warsaw

Brief Summary:

The aim of the study is to compare the effects of torasemide and furosemide on clinical and biochemical parameters of hemodynamic and neurohormonal compensation and myocardial remodeling in patients with chronic heart failure with indications for use of loop diuretics.

The study protocol 100 patients with heart failure NYHA (New York Heart Association) II-IV (stable or exacerbation aligned cardiopulmonary at the time of enrollment, with a fixed-dose loop diuretics]) treated with optimal medical therapy as clinically indicated for use loop diuretics. Patients will be randomized to treatment with furosemide and torasemide (randomization 1 : 1). After randomization, furosemide will continue in its current fixed-dose or will be replaced by equipotential dose of torasemide (4:1). The minimal follow-up of patients in the study will be at least six months.


Condition or disease Intervention/treatment Phase
Heart Failure Drug: Furosemide Drug: Torasemide Phase 4

Detailed Description:

According to current guidelines, angiotensin converting enzyme inhibitors and beta-adrenolytics are the first-line treatment agents in patients with heart failure. In case of fluid retention, diuretics, as a part of symptomatic treatment, should be administered. In practice, the most common diuretic used in patients with heart failure is loop diuretic - furosemide. What is important, furosemide has no effect on patients' outcomes. Some studies showed unfavourable influence of this drug on rennin-angiotensin-aldosterone system.

Alternative loop diuretic, which may be administered in patients with heart failure is torasemide. Its longer elimination half-life time, similar diuretic effects, lower influence on electrolyte disorders and additional pleiotropic effects could make torasemide more beneficial than furosemide.

Accordingly, only direct comparison of furosemide and torasemide could present similarities and differences of these two agents.

The hypothesis of this study is that torasemide may present more favourable effects on some clinical parameters in patients with heart failure, than furosemide (e.g. clinical symptoms, biochemical parameters, activity of rennin-angiotensin-aldosterone system, side effects).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Impact of TORasemide oN hemodynAmic and Neurohormonal Stress, and carDiac remOdeling in Heart Failure - Prospective, Randomized, Open, Blinded Endpoint Trial
Study Start Date : September 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: Furosemide
This group will receive furosemide as a diuretic treatment
Drug: Furosemide
Drug will be administered per os. Dose of the agent will be adapted to clinical status of the patient. Equipotential dose for furosemide is torasemide in dose 1:4 of furosemide

Experimental: Torasemide
This group will receive torasemide as a diuretic treatment
Drug: Torasemide
Drug will be administered per os. Dose of the agent will be adapted to clinical status of the patient. Equipotential dose for furosemide is torasemide in dose 1:4 of furosemide




Primary Outcome Measures :
  1. The influence of therapy on cardiovascular events associated with heart failure (deaths, hospitalisations) [ Time Frame: up to 12 months ]

Secondary Outcome Measures :
  1. The change of dosing of diuretic due to worsening of condition of patient. [ Time Frame: up to 12 months ]
  2. The change of NYHA (New York Heart Association) class - worsening or improvement [ Time Frame: up to 12 months ]

Other Outcome Measures:
  1. The measurement of fluid retention with ZOE Fluid Status Monitor [ Time Frame: up to 12 months ]
  2. ≥30% or ≥200 pg/ml increase of NTproBNP (N-terminal pro B type natriuretic peptide) level compared with baseline value [ Time Frame: up to 12 months ]
  3. The change between baseline and final levels of serum biomarkers [ Time Frame: up to 12 months ]
  4. The assessment of quality of life [ Time Frame: up to 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • heart failure NYHA II-IV
  • previous treatment with diuretics
  • age>18 years

Exclusion Criteria:

  • uncontrolled hypertension
  • uncontrolled diabetes
  • creatinine > 2,5 mg/dl
  • potassium > 6 mg/dl
  • acute coronary syndrome
  • hypertrophic cardiomyopathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01942109


Contacts
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Contact: Marcin Grabowski, PhD +48 660 751 816 marcin.grabowski@wum.edu.pl
Contact: Paweł Balsam, PhD +48 605152120 pawel.balsam@me.com

Locations
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Poland
3rd Clinic of Internal Medicine and Cardiology of Medcial University of Warsaw Not yet recruiting
Warsaw, Mazowieckie, Poland, 00-382
Contact: Andrzej Folga, PhD    +48 509 935 844    and.folga@gmail.com   
Principal Investigator: Andrzej Folga, PhD         
Sub-Investigator: Artur Mamcarz, Professor         
Sub-Investigator: Marcin Wełnicki         
Sub-Investigator: Daniel Śliż, PhD         
1st Department of Cariology of Medcial University of Warsaw Recruiting
Warsaw, Mazowieckie, Poland, 02-097
Contact: Marcin Grabowski, PhD    +48 660 751 816    marcin.grabowski@wum.edu.pl   
Principal Investigator: Marcin Grabowski, PhD         
Sub-Investigator: Grzegorz Opolski, Professor         
Sub-Investigator: Paweł Balsam, PhD         
Sub-Investigator: Renata Główczyńska, PhD         
Sub-Investigator: Eliza Kozyra-Pydys, MD         
Sub-Investigator: Krzysztof J Filipiak, Professor         
Sub-Investigator: Michał Peller, M.D.         
Sponsors and Collaborators
Medical University of Warsaw
Investigators
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Study Chair: Marcin Grabowski, PhD 1st Department of Cardiology Medical University of Warsaw

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marcin Grabowski, PhD, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT01942109     History of Changes
Other Study ID Numbers: TORNADO KB/202/2013
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: June 2017
Keywords provided by Marcin Grabowski, Medical University of Warsaw:
heart failure
diuretics
furosemide
torasemide
Additional relevant MeSH terms:
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Furosemide
Heart Failure
Heart Diseases
Cardiovascular Diseases
Torsemide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents